Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome
mHealth
2 other identifiers
interventional
300
1 country
1
Brief Summary
The investigators propose to adopt sustainable community networks (in this case churches) to implement an integrated community-based screening that incorporates mobile health technology (mHealth) to make prenatal test results available at the point-of-delivery to guide medical management.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv
Started Sep 2016
Shorter than P25 for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 6, 2017
CompletedFirst Posted
Study publicly available on registry
January 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedOctober 17, 2017
October 1, 2017
1.3 years
January 6, 2017
October 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Reach
Reach will be calculated as: the proportion of enrolled pregnant women relative to eligible pregnant women in the study catchment area.
6 months
Effectiveness
Effectiveness will be determined by assessing the impact of the mHealth platform on key outcomes such as screening for HIV, HBV, and sickle cell genotype, and health care utilizations for follow up visits. This will be measured by calculating the percentage of pregnant women that used the "smart card" at the point-of-delivery.
6 months
Adoption
Adoption rates will be calculated using the proportion of interested health care settings to the total number eligible for participation.
6 months
Acceptability
The proportion of enrolled pregnant women who accept to use the smart card for their health care services
6 months
Study Arms (1)
Intervention
EXPERIMENTALmHealth intervention
Interventions
HBI participants who consent will be enrolled in this study and will have data collected from their community screening stored in a secure, web-based database. The stored data will be encrypted into a Quick Response code embedded in a "smart card." A unique identification number and participant's blood group type will be on the outside of the card. There will be no names or any other identifiers. Each participating center will identify a dedicated delivery room staff that will be trained to read the contents of the card using the cell phone application as well as enter new data in the participant's profile. When a participant presents at delivery without the card, information can still be obtained from the secure, web-based database and confirmed using the participant's name, date of birth and cell phone number. This information is provided to the clinician to guide management of the infant.
Eligibility Criteria
You may qualify if:
- Pregnant women; 18 years or older enrolled in the Healthy Beginning Initiative
- One of the three conditions - HIV, Hepatitis B, and Sickle cell trait/disease
You may not qualify if:
- Those who do not accept to have their information uploaded on the secure database
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Catholic Caritas Foundation
Makurdi, Benue State, Nigeria
Related Publications (3)
Ezeanolue EE, Obiefune MC, Yang W, Obaro SK, Ezeanolue CO, Ogedegbe GG. Comparative effectiveness of congregation- versus clinic-based approach to prevention of mother-to-child HIV transmission: study protocol for a cluster randomized controlled trial. Implement Sci. 2013 Jun 8;8:62. doi: 10.1186/1748-5908-8-62.
PMID: 23758933BACKGROUNDGbadamosi SO, Eze C, Olawepo JO, Iwelunmor J, Sarpong DF, Ogidi AG, Patel D, Oko JO, Onoka C, Ezeanolue EE. A Patient-Held Smartcard With a Unique Identifier and an mHealth Platform to Improve the Availability of Prenatal Test Results in Rural Nigeria: Demonstration Study. J Med Internet Res. 2018 Jan 15;20(1):e18. doi: 10.2196/jmir.8716.
PMID: 29335234DERIVEDEzeanolue EE, Gbadamosi SO, Olawepo JO, Iwelunmor J, Sarpong D, Eze C, Ogidi A, Patel D, Onoka C. An mHealth Framework to Improve Birth Outcomes in Benue State, Nigeria: A Study Protocol. JMIR Res Protoc. 2017 May 26;6(5):e100. doi: 10.2196/resprot.7743.
PMID: 28550003DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Public Health and Pediatrics
Study Record Dates
First Submitted
January 6, 2017
First Posted
January 23, 2017
Study Start
September 1, 2016
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
October 17, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share